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Rich-Mar HV 1000 Muscle Stimulator

by Rich-Mar Corp.

510(k) K920833

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SN Traditional NumberK920833 Date22 May 1992DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
IPF
Device Class
Class II
Regulation
21 CFR Part 890.5850
Advisory Committee
Physical Medicine
FDA Decision
SN

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Rich-Mar HV 1000 Muscle Stimulator is a device used in physical medicine for muscle stimulation. It is substantially equivalent for some indications as determined by FDA 510(k) clearance.

The device is supplied by Rich-Mar Corp. and was cleared through the traditional 510(k) pathway under product code IPF. It is intended for use in clinical settings as a muscle stimulator, with no claims made regarding sterility, single-use or reusable status, MRI safety, sizes, storage, or additional authorisations beyond the FDA 510(k) clearance.

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Questions

AI-generated answers, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Rich-Mar HV 1000 Muscle Stimulator used for?

    The Rich-Mar HV 1000 Muscle Stimulator is used in physical medicine for muscle stimulation, as indicated by its FDA 510(k) clearance for substantially equivalent indications in that clinical setting.

  • How is the Rich-Mar HV 1000 Muscle Stimulator supplied and cleared for use?

    The device is supplied by Rich-Mar Corp. and received FDA 510(k) clearance through the traditional pathway under product code IPF, with clearance granted on May 22, 1992, based on substantial equivalence for some indications.

  • Does the Rich-Mar HV 1000 Muscle Stimulator have any claims regarding sterility, reusability, or MRI safety?

    No claims are made regarding sterility, single-use or reusable status, or MRI safety for the Rich-Mar HV 1000 Muscle Stimulator, as these details are not specified in the device data or its FDA 510(k) clearance documentation.